POS1147 CHALLENGES IN CONDUCTING PRAGMATIC CARE STRATEGY STUDIES IN OSTEOPOROSIS: PATIENT PERCEPTIONS
Authors: L. Jackson, E. Mcneeley, N. C. Techarukpong, F. Mugeta, K. Aaron, A. Mudano, J. Merchant, K. Warren, J. Foster, K. Saag, M. Danila
Journal: Annals of the Rheumatic Diseases (2022)

Background Large pragmatic osteoporosis studies to improve outcomes are needed. Direct-to-patient studies have highest generalizability but achieving sufficient sample size is difficult; recruitment challenges represent an important consideration given limited participant eligibility and interest. The Fracture Liaison Service (FLS), a team approach to post-fracture care, is a secondary fracture prevention method that has significantly improved outcomes internationally. Objectives Our goal was to evaluate the interest, barriers, and lessons learned in recruiting participants for a future trial assessing remote FLS approaches for post-fracture care. Methods We used ICD10 fracture codes to identify patients &gt; 50 years of age with a documented hip/pelvis, spine, humerus, or wrist fracture in the previous 1 year. We excluded patients with i) prescriptions for osteoporosis medications (e.g., bisphosphonates, parathyroid hormone analogs, denosumab, romosozumab, raloxifene) in the prior 1 year; ii) an ICD10 code for end-stage renal disease, non-osteoporotic metabolic bone disease, malignant neoplasm, or motor vehicle accident. In December 2021, research assistants reviewed electronic health records (EHR) of potentially eligible patients for evidence of additional serious illness limiting life expectancy to &lt; 1 year or non-ambulatory status prior to fracture. Research assistants called preliminary eligible patients that met inclusion and exclusion criteria and asked them to complete a survey by phone. Interest in a FLS future clinical trial was evaluated using a Likert scale (1=“Definitely would not volunteer”, to 5=“Definitely would volunteer”). We used descriptive statistics to analyze baseline demographic, clinical characteristics, and interest. This pilot was approved by the UAB Institutional Review Board (IRB-300008310-005). Results We identified 1,577 patients &gt; 50 years of age with a fracture. After applying exclusion criteria, we identified 869 preliminary eligible patients. Over 3 weeks, we screened the medical records of a random sample of half of the preliminary eligible patient cohort (n=414), of whom we contacted 271 patients determined potentially eligible, and successfully reached 141 (52% of those contacted) by phone. A total of 108 (77% of those reached) persons, mean (SD) age 69.5 (11.5) years, 40% men, 21% Black or non-white Hispanics completed the survey. Among those contacted, 68 (63%, interest rate) said they would be very or highly interested in participating in a future clinical trial evaluating FLS approaches. Among the 40 (37%) people who said they were not sure, unlikely or very unlikely to volunteer the most common reasons cited were “I don’t want to participate in a study” (33%); “I don’t feel well enough to participate” (10%); “I don’t understand what the study is for” (3%). From this pilot, we calculated a refined eligibility/interest rate of 9.1% among those patients preliminarily identified as eligible using administrative data alone. Conclusion Based on our pilot, we estimate that approximately 9% of eligible patients with fractures will be interested in enrolling in a future comparative effectiveness study to prevent recurrent fragility fractures. We identified several potential modifiable barriers to clinical trial recruitment. Patient perceptions collected from this pilot will inform enrollment strategies, which can be incorporated early when planning direct-to-patient pragmatic osteoporosis studies to achieve recruitment goals. Disclosure of Interests Lesley Jackson: None declared, Ellen McNeeley: None declared, Norma C. Techarukpong: None declared, Faith Mugeta: None declared, Kiara Aaron: None declared, Amy Mudano: None declared, Jeanne Merchant: None declared, Kellie Warren: None declared, Jeff Foster: None declared, Kenneth Saag Grant/research support from: Amgen, Horizon, LG Chem, Radius, SOBI, Maria Danila Grant/research support from: Pfizer, Horizon